DEVICE: SplashMax® (D813SPD16091)

Device Identifier (DI) Information

SplashMax®
SPD1609
In Commercial Distribution
SPD1609
DEN-MAT HOLDINGS, LLC
D813SPD16091
HIBCC

8
809857704 *Terms of Use
SPLASHMAX BLK PK LT HT 8PK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
ELW Material, Impression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Do not expose to direct sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

983ee8a6-e020-481c-8f1a-942f31ba312c
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: D813SPD16090 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
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